Agency
The FDA regulates food, drugs, biologics, medical devices, and tobacco. We aggregate Class I, II, and III enforcement actions across its three recall streams.
The FDA is the single biggest source of US product recalls by volume. Its enforcement workload splits into three streams — Foods (everything from infant formula to leafy greens to nutritional supplements), Drugs (prescription medicines, over-the-counter products, and active pharmaceutical ingredients), and Medical Devices (everything from implants to home blood-pressure monitors). The Recall Desk ingests all three from the openFDA enforcement endpoint every six hours.
FDA classifies every recall as Class I, II, or III. Class I means there is a reasonable probability that using the product will cause serious health consequences or death — these are the recalls you should treat as urgent. Class II means the product may cause temporary or medically reversible harm. Class III means the product is unlikely to cause adverse health consequences but still violates FDA rules. We map these classifications into our 1–5 severity score using the rubric on the methodology page.
Medical-device recalls are the highest-volume stream by far — software-update letters, calibration corrections, and IFU updates all show up in enforcement reports alongside genuine hazard recalls. We try to surface the severe ones first, but when in doubt, click through to the FDA notice itself for the clinical detail.
Merit Medical Systems is recalling Prelude IDEAL 4F Hydrophilic Sheath Introducer units (Lot H3082668) that contain 5F dilators instead of the labeled 4F dilators, which may result in procedure delay.
Consumer Product Partners is recalling Hydrogen Peroxide Topical Solution bottles with incorrect back labels indicating 91% Isopropyl Alcohol. The labeling mixup affects 25,932 bottles distributed in Virginia.
U.S. Trading Company recalled dried lily flowers due to undeclared sulfites, which pose a risk to people with sulfite sensitivity. The recall affected 5,200 packages distributed across 32 states and was terminated July 1, 2025.
Zimmer recalls 76 NexGen LPS Flex knee prosthesis units due to conflicting plate compatibility information on the product label.
Veridance Pharmacal is recalling 450 bottles of Omni-Macs McDonagh Medical Center Dietary Supplement because iodine levels exceed what is claimed on the label. One customer in Gladstone, Missouri received the affected product.
Smiths Medical is recalling ProPort Plastic implantable port systems because the plastic port housing and port reservoir may separate due to a manufacturing defect. The recall affects 2,311 units distributed worldwide.
Smiths Medical has recalled 643 ProPort Plastic implantable venous access ports that may separate due to a manufacturing defect. The recall affects units distributed worldwide.
Smiths Medical is recalling ProPort Plastic Venous Access Ports because the port housing and reservoir may separate due to a manufacturing defect. Contact your physician if you have an affected device.
Lyons Magnus is recalling Ready Care and Imperial brand Strawberry Shakes (No Sugar Added) due to potential Listeria monocytogenes contamination. The affected products were distributed to healthcare facilities nationwide.
Smiths Medical is recalling 9,506 ProPort implantable venous access ports due to a manufacturing defect that may cause the port housing and reservoir to separate. No injuries have been reported.
Smiths Medical is recalling ProPort Low Profile Plastic Venous Access Systems because the plastic port housing and reservoir may separate due to a manufacturing defect. Approximately 8,515 units worldwide are affected.
Daily Veggies Enoki Mushroom from New Age International is being recalled because of Listeria monocytogenes contamination. Consumers who purchased this product should not consume it.
Smiths Medical is recalling the ProPort Plastic Venous Access System due to a manufacturing defect that may cause the plastic port housing and reservoir to separate.
Two chocolate shake products from Lyons Magnus are being recalled due to potential Listeria monocytogenes contamination affecting approximately 763,250 cases distributed to healthcare facilities nationwide.
Lyons Magnus LLC is recalling Ready Care Strawberry Shake Plus (4 oz) due to potential Listeria monocytogenes contamination. The affected product has been distributed to healthcare facilities nationwide.
Lyons Magnus is recalling Ready Care and Imperial Vanilla Shake products for potential Listeria monocytogenes contamination. The affected products were distributed to healthcare facilities nationwide.
Lyons Magnus LLC is recalling Ready Care and Imperial Chocolate Shakes due to potential Listeria monocytogenes contamination. The recalled products were distributed nationwide to healthcare facilities and long-term care settings.
The ProPort Low Profile Plastic Venous Access System is being recalled because the port housing and port reservoir may separate due to a manufacturing defect, affecting approximately 2,236 units distributed worldwide.
Smiths Medical is recalling ProPort Plastic Venous Access Systems due to a manufacturing defect that can cause the port housing and reservoir to separate. This may result in device failure affecting patients worldwide.
Smiths Medical is recalling its ProPort Plastic Implantable Ports due to a manufacturing defect that may cause the port housing and reservoir to separate, potentially compromising device function.
Lyons Magnus LLC is recalling Ready Care and Imperial Strawberry Shake products due to potential Listeria monocytogenes contamination. The recall affects 763,250 cases distributed to healthcare facilities.
Lyons Magnus LLC is recalling Ready Care Vanilla Shake Plus (4 oz, UPC 10045796017549) due to potential contamination with Listeria monocytogenes. The product was distributed to hospitals, nursing homes, and long-term care facilities across the United States.
Lyons Magnus LLC is recalling Ready Care and Imperial brand vanilla shakes (4 oz) due to potential Listeria monocytogenes contamination. The affected products were distributed to long-term care facilities, skilled nursing homes, and hospitals across the U.S.
Ready Care and Imperial Strawberry Banana Shakes are being recalled due to potential Listeria monocytogenes contamination. The affected products were distributed to long-term care facilities, hospitals, and nursing homes.
Smiths Medical is recalling certain ProPort Plastic Venous Access System devices due to a manufacturing defect that may cause the port housing and reservoir to separate.